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steerable intracardiac catheter introducer kit and transseptal needle
Synaptic Medical
Summary: The steerable intracardiac catheter introducer kit by Synaptic Medical is used for transseptal access in cardiac procedures. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K151936 ↗
Decision Date
December 4, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on December 4, 2015. It is manufactured by Synaptic Medical and classified as a Class 2 device under product code DYB.
What It Is
The steerable intracardiac catheter introducer kit is a medical device designed to facilitate transseptal access to the left atrium of the heart. It includes a steerable sheath and a transseptal needle, allowing precise navigation and puncture of the atrial septum. This device is crucial in procedures requiring access to the left side of the heart, such as catheter ablations.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures like atrial fibrillation ablation. It is essential for cardiologists and electrophysiologists who perform transseptal punctures to access the left atrium. The device is typically used in hospital settings, particularly in patients requiring complex cardiac interventions.
Indications for Use
The device is indicated for use in patients needing transseptal access for procedures involving the left atrium. This includes conditions like atrial fibrillation where precise catheter placement is necessary.
Practical Considerations
The introducer kit is available in various sizes to accommodate different patient anatomies. It is compatible with standard electrophysiology lab equipment. Clinicians should be familiar with transseptal puncture techniques to ensure safe and effective use.
Frequently Asked Questions
What is the steerable intracardiac catheter introducer kit used for?
It is used for transseptal access to the left atrium during cardiac procedures like catheter ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for transseptal access in procedures involving the left atrium, such as in patients with atrial fibrillation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.